Job Opportunity:
We are recruiting for a position with a multinational organization.
This is an excellent opportunity to join a company renowned for its excellence in the industry.
Duties and Responsibilities:
* Develop and qualify cleaning cycles, execute equipment qualification.
* Coordinate validation strategies, write protocols, submit samples, analyze test results, prepare technical reports.
* Execute routine business activities such as periodic reviews, cleaning reviews, CAPAs, deviations, change control, risk assessments.
* Support commissioning by reviewing documents.
* Ensure documentation complies with standards.
* Participate in cross-functional problem-solving teams for troubleshooting and investigations.
* Prepare technical reports, perform statistical analysis of data.
* Adhere to regulatory guidelines.
* Represent the team on project teams.
* Provide technical input, present as SME during regulatory inspections.
* Adhere to highest standards for Compliance (Quality and Safety).
* Ensure compliance with site EHS policy, cGMP and other business regulations.
* Support Technical IPT input to risk assessments, audits, regulatory inspections, and incident investigations.
* Participate and comply with QMS requirements.
Requirements:
* Experience as a validation specialist in a pharmaceutical or highly regulated environment.
* Bachelor's Degree or other qualification in Chemical Engineering, Biochemistry, Microbiology, Chemistry, or related field.
* Experience in C&Q validation, Cleaning Validation, Equipment validation, Process operations or manufacturing, Process Engineering.
* Working knowledge of GxP systems associated with this role, including GLIMS and eVAL, electronic batch records.